NCT05857085

Brief Summary

The aim of study is impact of additional treatment with new antidiabetic drugs (semaglutide or empagliflozine) compared to control group in T1DM patients - impact on endothelial function measured by FMD and FPF, arterial stiffness - measured by PWV, inflammatory biomarkers, markers of oxidative stress and endothelial progenitor cells (CD 34+/VDRL2, CD 133+/VDRL2) and correlation with glucovariability or time in range, measured with CGM system.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
90

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Dec 2021

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 29, 2020

Completed
1.2 years until next milestone

Study Start

First participant enrolled

December 15, 2021

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 10, 2022

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 20, 2023

Completed
22 days until next milestone

First Posted

Study publicly available on registry

May 12, 2023

Completed
Last Updated

May 12, 2023

Status Verified

May 1, 2023

Enrollment Period

3 months

First QC Date

September 29, 2020

Last Update Submit

May 10, 2023

Conditions

Endothelial DysfunctionDiabetes Mellitus, Type 1BiomarkersEndothelial Progenitor CellsSGLT 2 InhibitorsIncretinsGlucose ExcursionsFMDFPFArterial Stiffness

Outcome Measures

Primary Outcomes (3)

  • evaluation of endothelial function by flow mediated dilation (FMD) of brachial artery

    measurement of dilation of brachial artery (in %) before and after postishemic hyperemia comparing two therapeutic groups and control group before and after intervention

    12 weeks

  • evaluation of endothelial function by strain gauge plethysmography as change in forearm blood flow

    changes in tissue perfusion (ml/100 ml of tissue/min) measured with strange gauge plethysmography as formarm blood flow before and after postishemic reactive hyperemija comparing two therapeutic groups and control group before and after intervention

    12 weeks

  • evaluation of arterial stiffness with peak wave velocity ( PWV)

    measurements of the velocity (m/s) at which arterial blood pressure pulses propagate - comparing two therapeutic groups and control group before and after intervention

    12 weeks

Secondary Outcomes (3)

  • evaluation of change in inflammatory biomarkers

    12 weeks

  • evaluation of change in biomarkers of endothelial dysfunction

    12 weeks

  • evaluation of endothelial progenitor cells EPC count

    12 weeks

Other Outcomes (2)

  • body impedance measurements

    12 weeks

  • changes of glycemia endpoints glucovariability/time in range

    2 weeks

Study Arms (3)

GLP 1 agonist

ACTIVE COMPARATOR

semaglutide in titrating doses 0,25 to 1,0 mg - duration of treatment12 weeks adding to insulin sheme (MDI or CII)

Drug: Semaglutide Pen Injector [Ozempic]

SGLT 2 inhibitor

ACTIVE COMPARATOR

empagliflozin 25 mg - duration of treatment 12 weeks adding to insulin sheme (MDI or CII or hybride system)

Drug: Empagliflozin 10 MG

comparator

NO INTERVENTION

continuing treatment only with insulin sheme (MDI or CII or hybride system)

Interventions

Semaglutide Pen Injector [Ozempic]DRUG

GLP 1 agonist

GLP 1 agonist
Empagliflozin 10 MGDRUG

SGLT 2 inhibitor

SGLT 2 inhibitor

Eligibility Criteria

Age20 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • T1DM
  • HbA1C\<=9%
  • prone to CGM system
  • years

You may not qualify if:

  • HbA1C \>9%,
  • BMI\<22,
  • pregnancy or lactation,
  • known hypersensitivity to study drug,
  • malignant disease ( excluded \>5 years disease free, bazocellular or planocellular ca of skin),
  • liver cirrhosis child C,
  • eGFR\<60 ml/min,
  • chronic inflammatory disease,
  • proliferative diabetic rethinopathy,
  • MEN or medullary thyroid cancer in familly,
  • concomitant drugs with influence on glycemia and antiinflammatory influence (corticosteroids, immunosupresive therapy),
  • Major cardiovascular event last 2 months ( stroke, MI)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

General Hospital Celje

Celje, 3000, Slovenia

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Interventions

semaglutideempagliflozin

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesAutoimmune DiseasesImmune System Diseases

Study Officials

  • Andrej Janez, prof PhD

    General and teaching hospital Celje and UKC Ljubljana/Maribor

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: 2 therapeutic arms - adding empagliflozin or semaglutide to basic insulin treatment and control arm in type 1 diabetic patients
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 29, 2020

First Posted

May 12, 2023

Study Start

December 15, 2021

Primary Completion

March 10, 2022

Study Completion

April 20, 2023

Last Updated

May 12, 2023

Record last verified: 2023-05

Data Sharing

IPD Sharing
Will not share

Locations

SL(1)